MAUDE Adverse Event Report: 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN DEPUY PFC PS FEMUR; KNEE FEMORAL COMPONENT

Catalog Number UNK-KNEE

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 01/28/2014

Event Type  Injury  

Event Description

Patient was revised to address pain.Loosening of the femoral component and patella at the cement/implant interface was reported, as well as a large amount of osteolysis.Competitor cement was used at the time of original implantation.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device associated with this report was not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot code required was not provided.Requests for additional investigational inputs were made in accordance with (b)(4).No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should the additional information be received, the investigation will be re-opened.

• Brand Name: UNKNOWN DEPUY PFC PS FEMUR
• Type of Device: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): 1818910 DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): 1818910 DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3619997
• MDR Text Key: 4133021
• Report Number: 1818910-2014-12326
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-KNEE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 83